510(k) K801276

DUPONT PREP APPLI. FOR PHENOBARBITAL, by E.I. Dupont DE Nemours & Co., Inc. — Product Code DKH

K801276 is an FDA 510(k) premarket notification submitted by E.I. Dupont DE Nemours & Co., Inc. for the device "DUPONT PREP APPLI. FOR PHENOBARBITAL,". The FDA issued a decision of Substantially Equivalent on June 20, 1980. The device falls under product code DKH (Gas Chromatography, Diphenylhydantoin), a Class II device regulated under 21 CFR 862.3350. E.I. Dupont DE Nemours & Co., Inc. has at least 10 other 510(k) clearances on record.